Dissertation for obtaining of the Philosophy Doctor degree of in the field of
knowledge 22 specialty - Health Care, in speciality 14.01.11 - Cardiology. – Shupyk
National Healthcare University of Ukraine, Ministry of Health of Ukraine, Kyiv, 2023.
6
Cardiovascular diseases (CVDs) continue to occupy a leading place in the
structure of morbidity, mortality and disability of the world's adult population. Statistic
shows an annual mortality rate of 17.8 million people as a result of cardiovascular
pathology according to the Global Burden of Disease Study. This primarily concerns
coronary heart disease (CHD) – 50% and stroke – 35%.
Elevated blood pressure (BP) is the most important modified factor that
influences the progression and development of complications of coronary heart
disease. Arterial hypertension (AH) and CHD combined are the most common in the
older population, which worsens the condition of patients. AH affects about a third of
the adult population in Ukraine, and the lack of effective treatment remains an urgent
national problem it. Since hypertension development is associated with activation of
the renin-angiotensin-aldosterone system (RAAS), BP-lowering treatment is used to
blockade this system and can lead to a reduction in cardiovascular (CVA)
complications developing risk.
The dissertation describes an approach to optimize methods of pharmacological
correction of clinical and hemodynamic complications in patients with AH, CHD, postinfarction cardiosclerosis (PIC) using fixed combined therapy of CCB and RAS
blockers.
Patients were follow-up for 12 months to achieve the goal, including general
clinical examination, office BP measurements, 24-hour BP monitoring,
echodopplerography, to evaluate the effect of fixed combinations on intracardiac
hemodynamics, monitoring of the composite endpoint: cardiovascular death, repeated
MI, percutaneous coronary intervention (PCI), CABG, TIA, stroke, hospitalization for
heart failure (HF).
7
The research work was carried out taking into account of ethical principles for
research with the participation of people (Helsinki Declaration) and was conducted as
an open, controlled, comparative study in parallel groups. Informed consent was signed
with all participants of the study. The design of the study was approved by the Shupyk
National Healthcare University of Ukraine Ethics Commission.
The study examined 108 patients with CHD, PIC and AH whose diagnosis was
established according to European Society of Cardiology guidelines on the basis of
relevant complaints, anamnesis, physical examination data and results of general
clinical, laboratory and instrumental methods of examination.
Patients were divided into two groups. The first group patients (n = 50) were
assigned to receive a fixed combination of lisinopril and amlodipine (10 mg and 5 mg,
respectively), and the second group patients (n = 58) were treated with a fixed
combination of valsartan and amlodipine (160 mg and 5 mg, respectively).
No statistically significant differences were found in the analysis of office
blood pressure and 24-hour blood pressure monitoring between amlodipine with
lisinopril and amlodipine with valsartan groups. The detailed analysis revealed a
greater percentage of patients with target blood pressure below 130/80 mm Hg among
those under 65 years of age receiving amlodipine with lisinopril (χ2 = 3.52; P = 0.046).
The better prognostic value of the fixed combination of amlodipine with lisinopril
compared to the combination of amlodipine with valsartan (P = 0.007) was
demonstrated by the endpoint analysis.
